Tesamorelin

An FDA-approved GHRH analog specifically indicated for HIV-associated lipodystrophy that reduces visceral adipose tissue while preserving metabolic parameters.

Also known as: Egrifta, TH-9507

Regulatory Status

FDA-Approved

Classification date: 2010-11-10

Compounding: Not currently available for compounding

Evidence Summary

Strong20 human studies published

Key Studies

Effects of tesamorelin on visceral fat and metabolic parameters in HIV-infected patients with lipodystrophy
Tesamorelin reduces liver fat in HIV-associated NAFLD: a randomized controlled trial
GHRH analog tesamorelin improves cognition in healthy older adults and those with MCI

How It Works

Tesamorelin is a synthetic analog of human GHRH (1-44) with a trans-3-hexenoic acid modification that improves stability. It stimulates pulsatile GH release from the pituitary via the GHRH receptor, specifically targeting visceral fat reduction. In clinical trials it reduced trunk fat by approximately 18% in HIV-lipodystrophy patients. Unlike exogenous GH, it maintains physiologic feedback regulation and has demonstrated beneficial effects on liver fat (NAFLD) and cognitive function in aging adults in exploratory studies.

Common Applications

HIV-associated lipodystrophy (FDA-approved as Egrifta)Visceral fat reductionLiver fat reduction (NAFLD research)Cognitive function support (research stage)

Safety & Considerations

Common side effects include injection-site reactions (erythema, pruritus), arthralgia, peripheral edema, and myalgia. Carries a warning for potential promotion of pre-existing malignancies due to GH/IGF-1 elevation. Contraindicated in patients with active malignancy, pituitary surgery/disease, or known hypersensitivity. May impair glucose tolerance. Requires monitoring of IGF-1 levels. Approved specifically for HIV-lipodystrophy; off-label use is not FDA-sanctioned.

Regulatory classifications can change rapidly. The information shown here was last verified on 2010-11-10. Always confirm current legal status with a licensed provider or the FDA before making treatment decisions.